The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Philips Dsi System Release 3.2.
| Device ID | K920793 |
| 510k Number | K920793 |
| Device Name: | PHILIPS DSI SYSTEM RELEASE 3.2 |
| Classification | Camera, X-ray, Fluorographic, Cine Or Spot |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. VEENPLUIS 4-6 P.O. BOX 10000 5680 Da Best, NL |
| Contact | William G Mcmahon |
| Correspondent | William G Mcmahon PHILIPS MEDICAL SYSTEMS, INC. VEENPLUIS 4-6 P.O. BOX 10000 5680 Da Best, NL |
| Product Code | IZJ |
| CFR Regulation Number | 892.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-21 |
| Decision Date | 1992-07-17 |